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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSIMPSON CORONARY ATHEROCATH(TM)
Classification Namecatheter, coronary, atherectomy
ApplicantDEVICES FOR VASCULAR INTERVENTION, INC.
PMA NumberP890043
Supplement NumberS008
Date Received01/30/1991
Decision Date02/21/1991
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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